BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® SPINAL ANESTHESIA TRAYS

    MDR report key: 7508213 · Received May 11, 2018

    Report

    Report Number
    3012307300-2018-10245
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    January 17, 2017
    Report Date
    May 11, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    UDI-DI
    20351688082333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS AND INCOMING RECORDS FOUND NO DISCREPANCIES OR ANOMALIES RELEVANT TO THE COMPLAINT. ASSAY TESTING, PERFORMED BY THE SUPPLIER PRIOR TO RELEASE OF BUPIVACAINE-MARCAINE LOT # 641003A, LIDOCAINE LOT # 63-384-EV AND EPINEPHRINE LOT # 631053A, WAS WITHIN SPECIFICATION. REVIEW OF THE STERILIZATION CERTIFICATE FOR THE TRAY LOT NUMBER 3241851 ((B)(4)) REVEALED THAT THE PRODUCT WAS PROCESSED ACCORDING TO VALIDATED SPECIFICATION REQUIREMENTS AND PARAMETERS. SMITH MEDICAL PERIODICALLY MONITORS SUPPLIED DRUG COMPONENTS STABILITY POST ETHYLENE OXIDE STERILIZATION THROUGHOUT THEIR EXPIRY. OUR RECORDS SHOW THAT THE SUPPLIED DRUGS COMPONENTS CONTINUE TO MEET POTENCY SPECIFICATIONS. COMPLAINT HISTORY REVIEW DOES NOT INDICATE ANY UPWARD TRENDS FOR THE DRUG LOT NUMBERS, REPORTED IN THIS COMPLAINT. THE ANESTHETICS ARE SUPPLIED ITEMS AND THE COMPLAINT NOTIFICATION WAS FORWARDED TO THE SUPPLIER. POSSIBLE CAUSES OF LACK OF EFFECT MAY BE ADMINISTRATION TECHNIQUE OR PATIENT ANATOMICAL VARIATIONS, INCLUDING PATHOLOGICAL OR PSYCHOLOGICAL

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MARCAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AS A RESULT. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349244 PORTEX® SPINAL ANESTHESIA TRAYS ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD, INC. 3241851 20351688082333

    Patients

    Seq Age Sex Outcome Treatment
    1